CholangiocarcinomaNCT03211169
Comparison Bile Duct Brushings, Cholangioscopy-Directed Biopsies and Pediatric Forceps Biopsies in Biliary Strictures
A study testing Biopsies of bile duct stricture with pediatric biopsy forceps and Biopsies of bile duct stricture with cholangioscopy-directed biopsies in people with Cholangiocarcinoma and Stricture; Bile Duct, run by Stanford University at 1 site in United States.
Trial summary
Prospective, randomized, multi-center study. Investigators will compare diagnostic yield of bile duct brushings, pediatric biopsy forceps biopsies and cholangioscopy-directed biopsies for obtaining diagnostic tissue from biliary strictures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholangiocarcinoma, Stricture; Bile Duct
- What is being tested?
- Biopsies of bile duct stricture with pediatric biopsy forceps and Biopsies of bile duct stricture with cholangioscopy-directed biopsies
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jul 2017to 1 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients with obstructive jaundice, and imaging (CT or MRI) suggestive of biliary stricture, without obvious pancreatic mass
- All patients with obstructive jaundice, and index ERCP suggestive of biliary stricture, without obvious pancreatic mass
- All patients with obstructive jaundice, and prior ERCP suggestive of biliary stricture
- Expected patient survival of at least 90 days
- High likelihood of patient follow-up
- Patient is able to give a written informed consent
- Patient is willing and able to comply with the study procedures
Who cannot join
- Patients with imaging suggestive of pancreatic tumor
- Children < 18 years of age
- Pregnant women
- Patients with impaired decision-making
- Healthy volunteers
- Primary Sclerosing Cholangitis (PSC)
Show all 10Show fewer
- Patients with untreated coagulopathy at the time of procedure or ongoing need for anti-coagulation
- Patients with any contraindication to endoscopic procedure
- Participation in another investigational study that may directly or indirectly affect the results of this study within 30 days prior to the initial visit
- Patients unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University Medical Center
Stanford, California, 94305
About this study
Official title: Comparative Efficacy of Bile Duct Brushings, Cholangioscopy-Directed Biopsies and Pediatric Forceps Biopsies for Obtaining Diagnostic Tissue From Indeterminate Biliary Strictures
Prospective, randomized, multi-center study. Investigators will compare diagnostic yield of bile duct brushings, pediatric biopsy forceps biopsies and cholangioscopy-directed biopsies for obtaining diagnostic tissue from biliary strictures.
- Conditions
- Cholangiocarcinoma, Stricture; Bile Duct
- Being tested
- Biopsies of bile duct stricture with pediatric biopsy forceps, Biopsies of bile duct stricture with cholangioscopy-directed biopsies
- Medical subject headings
- Cholangiocarcinoma, Constriction, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biopsies of bile duct stricture with pediatric biopsy forcepsProcedure or surgery
Biopsies of the stricture will be taken to evaluate diagnostic yield of Pediatric Biopsy Forceps
Biopsies of bile duct stricture with cholangioscopy-directed biopsiesProcedure or surgery
Biopsies of the stricture will be taken to evaluate diagnostic yield of cholangioscopy-directed biopsies
| Study group | Role | What they receive |
|---|---|---|
| Pediatric Biopsy Forceps directed biopsies | Experimental | Biopsies of the stricture will be taken with Pediatric Biopsy Forceps after bile duct brushings have been obtained. Receives: Procedure: Biopsies of bile duct stricture with pediatric biopsy forceps |
| Cholangioscopy-directed biopsies | Active comparator | Biopsies of the stricture will be taken under cholangioscopic guidance after bile duct brushings have been obtained. Receives: Procedure: Biopsies of bile duct stricture with cholangioscopy-directed biopsies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic tissue obtained as assessed by histologic evaluation of biopsy specimen
Malignancy or no malignancy diagnosis obtained from stricture biopsy
Measured: 1 week
Secondary outcomes (5)
Cost
Cumulative $ from devices used and facility fees with each approach
Measured: 2 years
Radiation Exposure
Total Dose, Fluoroscopy Time, Dose Area Product, Effective dose per fluoroscopy machine readings
Measured: 2 years
Procedure Duration
in minutes
Measured: 2 years
Latency to diagnosis
Duration in days from initial procedure to diagnosis of benign or malignant stricture
Measured: 2 years
Adverse Events
(Pancreatitis, Bleeding, Infection, Perforation, Death to be assessed one day, one week post-procedure
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2017
- Study start29 Jul 2017
- Primary completion1 Sep 2019
- Study completion1 Sep 2019
Why it stopped: Inadequate enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholangiocarcinomaStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized prospective study
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Subhas Banerjee, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03211169
- Sponsor's protocol ID
- 40988
- Status last verified
- Nov 2019
- First submitted
- 30 Jun 2017
- Last updated
- 8 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Efficacy of Bile Duct Brushings, Cholangioscopy-Directed Biopsies and Pediatric Forceps Biopsies for Obtaining Diagnostic Tissue From Indeterminate Biliary Strictures
- ClinicalTrials.gov ID
- NCT03211169
- Acronym / sponsor ID
- 40988
- Conditions
- Cholangiocarcinoma, Stricture; Bile Duct
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inadequate enrollment
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- University of Rochester, The University of Texas Health Science Center, Houston
- Study start
- 29 Jul 2017 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 7 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective, randomized, multi-center study. Investigators will compare diagnostic yield of bile duct brushings, pediatric biopsy forceps biopsies and cholangioscopy-directed biopsies for obtaining diagnostic tissue from biliary strictures.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized prospective study
| Arm | Type | Receives |
|---|---|---|
| Pediatric Biopsy Forceps directed biopsies | Experimental | Procedure: Biopsies of bile duct stricture with pediatric biopsy forcepsBiopsies of the stricture will be taken with Pediatric Biopsy Forceps after bile duct brushings have been obtained. |
| Cholangioscopy-directed biopsies | Active comparator | Procedure: Biopsies of bile duct stricture with cholangioscopy-directed biopsiesBiopsies of the stricture will be taken under cholangioscopic guidance after bile duct brushings have been obtained. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- All patients with obstructive jaundice, and imaging (CT or MRI) suggestive of biliary stricture, without obvious pancreatic mass
- All patients with obstructive jaundice, and index ERCP suggestive of biliary stricture, without obvious pancreatic mass
- All patients with obstructive jaundice, and prior ERCP suggestive of biliary stricture
- Expected patient survival of at least 90 days
- High likelihood of patient follow-up
Key exclusion criteria (10 listed)
- Patients with imaging suggestive of pancreatic tumor
- Children < 18 years of age
- Pregnant women
- Patients with impaired decision-making
- Healthy volunteers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biopsies of bile duct stricture with pediatric biopsy forcepsBiopsies of the stricture will be taken to evaluate diagnostic yield of Pediatric Biopsy Forceps | Procedure or surgery | Pediatric Biopsy Forceps directed biopsies |
| Biopsies of bile duct stricture with cholangioscopy-directed biopsiesBiopsies of the stricture will be taken to evaluate diagnostic yield of cholangioscopy-directed biopsies | Procedure or surgery | Cholangioscopy-directed biopsies |
Primary outcome
Diagnostic tissue obtained as assessed by histologic evaluation of biopsy specimen
Time frame: 1 week
Malignancy or no malignancy diagnosis obtained from stricture biopsy
5 secondary outcomes
Cost
Time frame: 2 years
Radiation Exposure
Time frame: 2 years
Procedure Duration
Time frame: 2 years
Latency to diagnosis
Time frame: 2 years
Adverse Events
Time frame: 2 weeks
Results and safety
The study was stopped early (reason given: Inadequate enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biopsies of bile duct stricture with pediatric biopsy forceps and Biopsies of bile duct stricture with cholangioscopy-directed biopsies in people with Cholangiocarcinoma and Stricture; Bile Duct, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Inadequate enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic tissue obtained as assessed by histologic evaluation of biopsy specimen (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2019.